Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

I. IMPORTATION
PRODUCT
CATEGORY

PRODUCT
DESCRIPTION
OR FORM

REQUIREMENTS FOR RELEASE

Valid LTO

Valid
CPR

a. Finished product LTO as DI

Yes

b. Finished product LTO as

in bulk
DM or as
DT

No

A. DRUGS

c. Raw mats for

own use

LTO as
DM or as
DT

No

d. Raw mats for

local sale or
distribution

LTO as DI

No

NN

E-Reg

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

PRODUCT
CATEGORY

PRODUCT
DESCRIPTION OR
FORM

REQUIREMENTS FOR RELEASE

Valid LTO

Valid
CPR

a. Finished product

LTO as FI

Yes

b. Raw mats, food

ingredients,
additives for own
use

LTO as
FM/I or as
FT/I

No

c. Raw mats, food

ingredients,
additives, for
local sale or
distrib

LTO as FI

Yes

d. Finished product
for packing

LTO as
FT/I

Valid NN

E-Reg
(Low
Risk)

B. Processed
Food

Yes

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

PRODUCT
CATEGORY

PRODUCT
DESCRIPTION OR
FORM

REQUIREMENTS FOR RELEASE

Valid LTO

Valid
CPR

B. Processed
Food

Under FFL

Wheat Flour,
Cooking Oil,
Sugar

LTO as FI

Yes

Under ASIN

Iodized Salt

LTO as FI

Yes

Valid NN

E-Reg
(Low
Risk)

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

PRODUCT
CATEGORY

PRODUCT
DESCRIPTION OR
FORM

REQUIREMENTS FOR RELEASE

Valid LTO

a. Finished product

LTO as CI

Yes

HUHS

a. Finished product

LTO as
HUHS/I

Yes

Pesticides

a. Finished product

LTO as
HUHS/I

Yes

b. Raw mats

LTO as
HUHS/I

Yes

a. Finished product

LTO as
HUHS/I

Valid
CPR

Valid NN

C. Cosmetics

Toys below
14 years old

Yes

E-Reg
(Low
Risk)

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

PRODUCT
CATEGORY

PRODUCT
DESCRIPTION OR
FORM

REQUIREMENTS FOR RELEASE

Valid LTO

Valid
CPR

D. Medical
Devices
a. Finished product

Radiation
Emitting
Device

Health-related
Device

LTO as
MDI

Yes

Certificate
for
Customs
Release
(CFCR)
Water Filtration
Purification Device
Hospital waste
Disinfection Device

Yes

Valid NN

E-Reg
(Low
Risk)

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

II. EXPORTATION
PRODUCT
CATEGORY

PRODUCT
DESCRIPTION OR
FORM

REQUIREMENTS FOR RELEASE

Valid LTO

Valid
CPR

DRUGS

LTO as
Exporter

Yes

Processed
Foods

LTO as
Exporter

Yes

Cosmetics

LTO as
Exporter

Medical
Devices

LTO as
Exporter

Valid NN

Yes
Yes or
COPE

E-Reg
(Low
Risk)

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

III. OTHERS
PURPOSE OF
IMPORTATION

REQUIREMENTS PRIOR TO
BOC RELEASE

Donation: Drugs

FDA Certification/Clearance

Donation: Medical Devices

FDA Certification/Clearance

Donation: Processed Food

FDA Certification/Clearance

Research

FDA Certification/Clearance

Clinical Trials

Import Permit

Exhibits/ Trade Promotion

FDA Certification/Clearance
(except Drugs)

Samples for Product

Registration

FDA Certification/Clearance

Compassionate Use

Import Permit

Personal Use

REMARKS
Subject to FDA inspection
and collection of
representative samples for
ACPR

Subject to Inspection

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

FDA does not

encourage its
regulated products
for
AUCTION

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

In case where LTO/ CPR are

undergoing renewal process, the
ff can be accepted so as not to
disrupt continuity of business:
DTN (within 6 months from date of application of
renewal)
Official Receipt of Payment for renewal

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

THANK YOU!